Associate Director, Drug Product Development

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $150k - $202.4k / year

⏰ Full Time

🟠 Senior

👔 Director

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities • Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation • Provide technical leadership for clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, and investigations as applicable • Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges, ensuring timely resolution of technical issues • Contribute to the development of process validation strategies for drug product manufacturing in collaboration with internal and external stakeholders • Oversee preparation, review, and approval of process validation documentation, including process performance qualification (PPQ) protocols/reports, risk assessments, control strategies, and continued process verification plans • Evaluate manufacturing performance data to identify trends, process capability concerns, and opportunities for continuous improvement • Lead secondary packaging development activities for a drug product in late-stage development • Support development of packaging design, component selection, labeling configuration inputs, packaging line considerations, and secondary packaging validation activities with external partners and internal stakeholders

🎯 Requirements

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline • 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions • Demonstrated experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment • Strong working knowledge of: • cGMP requirements for OSD manufacturing • Drug product process development, formulation development, tech transfer, scale-up, and PPQ • ICH Q8/Q9/Q10 and risk‑based validation principles • Manufacturing investigations and change management • Proven ability to technically oversee and influence external manufacturing partners.

🏖️ Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave and some fun fringe perks!